INNOVA E4 WASHER-DISINFECTOR (2016-03-16)

Starting date:

March 16, 2016

Posting date:

April 4, 2016

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-57744

• Reason
• Affected products

Affected Products

INNOVA E4 WASHER-DISINFECTOR

Reason

A hospital contacted SciCan on March 10, 2016 to report difficulties with one of their E4-WD Washer-Disinfectors. The hospital's biomedical technician reported that he identified the upper water flap of one channel being stuck in the closed position. According to the hospital's biomedical technician, a screw securing the water flap was suspected to be responsible for this issue. That specific screw was apparently loose and deflected the stainless steel insert spacer from its normal position causing it to miss the water flap which consequently remained closed. As the water flap was stuck in the closed position, it did not allow the proper circulation of water and chemicals in the upper scope. The scopes located in that specific location were not reprocessed correctly. The biomedical technician has confirmed that this water flap was opening correctly until March 9th, 2016.

Affected products